FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Endoscopy Adapter Set
K Number: K220210
·
Decision Jun 17, 2022
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
71
Applicant Total
8
Review Days
142
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Basic Information
- Device Name
- Disposable Endoscopy Adapter Set
- K Number
- K220210
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- Date Received
- January 26, 2022
- Decision Date
- June 17, 2022
- Product Code
- ODC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Yangzhou Fartley Medical Instrument Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260423 | Disposable Endoscopic Distal Attachments | May 28, 2026 | Substantially Equivalent |
| K250732 | Disposable Endoscopy Valve Set | Jun 20, 2025 | Substantially Equivalent |
| K230004 | Disposable Hemoclip | Jul 31, 2023 | Substantially Equivalent |
| K222980 | Pentax Medical Valve Set | Nov 21, 2022 | Substantially Equivalent |
| K220785 | Clean Connecting Tube | Sep 27, 2022 | Substantially Equivalent |
| K220292 | Disposable Endoscope Injection Needle | Aug 19, 2022 | Substantially Equivalent |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare | Jun 27, 2022 | Substantially Equivalent |